FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOSPITALIER WHEELCHAIR
K Number: K840637
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
17
Review Days
38
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Basic Information
- Device Name
- HOSPITALIER WHEELCHAIR
- K Number
- K840637
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Poirier S.A.
- Date Received
- January 20, 1984
- Decision Date
- February 27, 1984
- Product Code
- IOR
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.
ICON 35; ICON 45; ICON 60; ICON 30FAF
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K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
FDA 510(k)
FDA Class 1
·Physical Medicine
Other Clearances by Poirier S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K840638 | PORTABLE TRANSIT CHAIR | Mar 16, 1984 | Substantially Equivalent |
| K840639 | POIRIER COMMODES | Mar 9, 1984 | Substantially Equivalent |
| K840636 | CHILDREN'S WHEELCHAIRS | Feb 27, 1984 | Substantially Equivalent |
| K840234 | POIRIER VARIABLE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840633 | AIRPORT WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840630 | POIRIER REGLADE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840626 | VERTICALIBRE WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840631 | ARNAS WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840625 | UNION WHEELCHAIR | Feb 27, 1984 | Substantially Equivalent |
| K840629 | WHEELCHAIR ACCESSORIES | Feb 27, 1984 | Substantially Equivalent |